Download The new trial results could help address a major dilemma for

News Release
June 20, 2017
Cleveland researchers call for paradigm shift in type 2 diabetes treatment
Four clinical trials suggest doctors focus on heart disease, not just glucose levels
Heart disease is a leading cause of death worldwide and exacerbated by type 2 diabetes, yet
diabetes treatment regimens tend to focus primarily on blood sugar maintenance. This common
approach to type 2 diabetes management can leave patients at risk for heart attack and stroke.
But results from four recent randomized clinical trials suggest that using medications that offer
glucose control while reducing the risk for cardiovascular disease could improve patient
outcomes.
"Strong evidence provided by the four recent trials published within the past 1.5 to 2 years in the
New England Journal of Medicine has shown that some of the modern available therapeutic
agents that control blood glucose also help reduce the risk for cardiovascular disease," said
Faramarz Ismail-Beigi, MD, PhD, Professor of Medicine at Case Western Reserve University
and Endocrinologist at University Hospitals Cleveland Medical Center and Louis Stokes
Cleveland VA Medical Center. "Based on this evidence, we propose that we must shift from our
previous paradigm with its monocular focus on control of blood glucose and hemoglobin A1c, to
one of control of blood glucose plus preventing cardiovascular disease and death from
cardiovascular causes." Hemoglobin A1c is a common test used to determine a patient's average
blood sugar levels over the previous 2-3 months.
Dr. Ismail-Beigi helped conduct three of the four clinical trials, and he and his collaborators
recently reviewed trial results in the Journal of General Internal Medicine. The trials each tested
a blood sugar-lowering medication--pioglitazone, empagliflozin, liraglutide, or semaglutide--but
recruited patients with heart disease or stroke. The goal was to determine whether or not the
drugs were safe, but in each study, researchers were surprised to find participants with or at risk
of type 2 diabetes also experienced cardiovascular improvements.
"For the first time we have seen glucose-lowering medications that can improve cardiovascular
outcomes," Dr. Ismail-Beigi said. "It is highly possible that newer agents in these classes of
medications, used singly or in combination, will prove to be more efficacious in the management
of type 2 diabetes and prevention of cardiovascular disease, even in patients at earlier stages of
the disease process."
Previous studies focused on tight control of blood sugar have not shown major cardiovascular
benefits for diabetes patients. "Strict control of blood glucose levels has shown minor, if any,
positive effect on prevention of cardiovascular disease," said Dr. Ismail-Beigi. "In fact, a large
NIH-funded clinical trial on type 2 diabetes management failed to show that strict control of
blood glucose levels had any positive effect on cardiovascular outcomes or mortality, and in fact,
may be harmful."
The new trial results could help address a major dilemma for clinicians looking for ways to
control heart disease and reduce mortality, while simultaneously managing blood glucose in
patients with type 2 diabetes.
Dr. Ismail-Beigi said, "Our review focuses on the need for a paradigm shift on how we should
think about management of type 2 diabetes. I believe it will necessitate a rethinking of goals and
approaches by guideline committees. We also hope that the FDA might consider approving new
medications for management of type 2 diabetes not only based on their safety profile and their
efficacy to control blood glucose, but also whether the medication reduces overall mortality and
cardiovascular-related mortality."
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Dr. Ismail-Beigi has received grants from the National Institutes of Health and Novo Nordisk to
conduct clinical trials. He has shares in Thermalin Diabetes, Inc., and serves as a consultant for
Sanofi and COVANCE.
For more information about Case Western Reserve University School of Medicine, please visit:
http://case.edu/medicine.
Media Contact
Marc Kaplan
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